Jasugrel 10mg daiichi medicine for unstable angina, myocardial infarction (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Prasugrel

Ingredient

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Composition information	Content
Prasugrel	10mg

Uses

Indication

Jasugrel is used in combination with acetylsalicylic acid (ASA), which is indicated in the prevention of thrombotic event in patients who are adults with acute coronary syndrome (e.g. unstable angina, myocardial infarction without ST segment [UA/NSTEI (PCI).

Pharmacokinatus

Pharmacological group treatment: Anti -platelet assembly is not Heparin

м а атс: b01ac22

Prasugrel is an active inhibitor and platelet aggregation through the non -restoration of the active metabolic substance with the P2Y12 group of the ADP receptor on platelets. Due to platelets involved in the process of booting and/or progression of thrombosis in atherosclerosis, inhibiting the function of platelets can reduce cardiovascular events such as death, myocardial infarction or stroke.

After using the 60 mg of prasugrel attack dose, the inhibitory effect of platelet aggregation through the ADP touch appears after 15 minutes with 5µm ADP and 30 minutes with 20µm ADP. The maximum platelet aggregation inhibitor via the ADP touch of Prasugrel is 83% with 5 µm ADP and 79% with 20µm ADP, in both cases 89% of healthy people and patients with atherosclerosis achieve stable inhibition rate of platelet aggregation at least 50% in 1 hour. The inhibitory effect of Prasugrel through plateletic intermediaries shows a low change among subjects (9%) and in each object (12%) at 5µm and 20µm ADP concentrations.

The average platelet aggregation inhibitors in a stable state are 74% and 69% at 5 µm and 20 µm ADP concentrations, achieved after 3 to 5 days of using Prasugrel maintenance dose of 10 mg at the next attack dose of 60 mg.

More than 98% of drug users achieve platelets inhibitors> 20% during the maintenance dose period.

The platelet aggregation process gradually returns to the original value before treatment after 7 to 9 days of stopping prasugrel attacks 60 mg and after 5 days after stopping the maintenance dose in a stable state.

Data conversion: After taking the dose of 75 mg Clopidogrel once a day for 10 days, 40 healthy people are switched to prasugrel 10 mg once a day with or without using 60 mg attack dose. Similar or higher platelet collection effect has been recorded with prasugrel.

pharmacokinetics

No data.

Before taking Jasugrel 10mg daiichi medicine for unstable angina, myocardial infarction (2 blisters x 14 tablets)

How to use

Jasugrel only taken orally. Jasugrel can be used or not with food. Take the dosage of 60 mg of prasugrel at hunger can create the fastest starting effect. Do not bite or break the tablet.

Dosage

adults

start using Jasugrel at a single dose of 60 mg, then continue taking 10 mg a day a day. In patients with unstable angina/myocardial infarction without the difference of St (Uanstemi), coronary angiography is within 48 hours after hospitalization, recommending the dosage of attack at the time of coronary intervention through the skin. Patients using Jasugrel should also use ASA daily (75 mg to 325 mg).

In patients with acute coronary syndrome (ACS), the skin is treated with coronary artery intervention, the early stopping of any anti -platelet aggregation, including Jasugrel, can increase the risk of thrombosis, myocardial infarction or patient's disease death. The recommendation of the drug lasts up to 12 months unless clinically stopped using Jasugrel.

Patient ≥ 75 years old

Due to the risk of hemorrhage (including death bleeding) and the effectiveness of the drug is unclear in patients ≥ 75 years old, it is not recommended to use Jasugrel for these patients, except for high risk (patients with diabetes or a history of myocardial infarction) in which the benefit of the drug is superior and the drug may be considered for use. After careful consideration of the benefits/risks in each patient, if it is necessary to treat the patient ≥ 75 years old, the treating doctor should prescribe 60 mg attack dose, then use the maintenance dose to decrease to 5 mg. Patients ≥ 75 years old are more sensitive to bleeding side effects and concentration of active metabolites of prasugrel in higher circulation in these patients.

Patient weight

Should use Jasugrel with an initial attack of 60 mg, then continue to maintain the dose of 5 mg once a day. It is not recommended to use the maintenance dose 10 mg once a day due to this dose that increases the concentration of metabolites that are active of prasugrel, increasing the risk of bleeding in patients with weight

kidney failure

No need to adjust the dose for patients with renal impairment, including patients with end -stage renal disease.

Hepatic failure

No need to adjust the dose for patients with mild to medium liver failure (classification of Childpugh A and B). Experience in using drugs for patients with mild and medium liver dysfunction is limited. Contraindicated to use Jasugrel in patients with severe liver failure (Child Pugh C).

Pediatric patients

The safety and effectiveness of Jasugrel in children under the age of 18 have not been determined. Research data on children with sickle cell anemia is very limited.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? There is no data on the reversal of pharmacological effects of Prasugrel; However, if it is necessary to quickly adjust the prolonged bleeding time, it is possible to consider platelet transmission and/or other blood products.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Notify the physician the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Jasugrel drugs are contraindicated in the following cases:

Hypersensitivity to the active ingredient or any ingredient of the drug.

Caution when using

Hemorrhage risk

In phase 3 clinical trial (triton), the main exclusion criterion includes patients with increased hemorrhage risk; anemia; thrombocytopenia; History of intracranial pathology. Patients with acute coronary artery syndrome intervened through the skin treated with Jasugrel and acetylsalicylic acid that increased the risk of serious occurrence and non -serious bleeding under the fibroid classification system in myocardial infarction (Timi). Therefore, Jasugrel should only be considered for patients at risk of bleeding when the prevention of prevention of necrotic anemia is superior to the risk of serious bleeding.

Need special attention in patients:

≥ 75 years old. In these patients, the maintenance dose of 10 mg is not recommended. The maintenance dose of 5 mg should be used.

On patients who are bleeding if they need to reverse the pharmacological effect of Jasugrel, platelets can be transmitted.

Due to the risk of hemorrhage (including fatal bleeding) and unclear effect in patients ≥ 75 years old, generally do not recommend using Jasugrel for these patients, except for patients with high risk (diabetes patients or a history of myocardial infarction) when the effectiveness of preventing the local anemia is superior to the risk of serious hemorrhage, the use of drugs may be used after the use Treatment has carefully assessed the benefits/risks on each object.

Using pregnant and lactating women

There are no clinical studies performed in pregnant and lactating women.

Pregnant women:

Animal studies do not indicate the direct harm of the drug in pregnant women, on the development of the fetus/ fetus, the reproductive process or development after birth. Because studies on animal fertility do not always reflect the response on humans, Jasugrel should only be used for pregnant women when the benefit of the drug with the mother outperforms the risk of harm to the fetus.

breastfeeding women:

It is unknown whether Prasugrel is excreted through breast milk or not. Animal studies show prasugrel excreted through breast milk. It is not recommended to use prasugrel during breastfeeding.

Reproduction:

Prasugrel does not affect fertility on both male and female rats at oral doses up to 240 times the maintenance dose recommended on human use (calculated by mg/m2 of the body area).

The effect of the drug on driving and operating machinery

There are no studies conducted on the ability to drive and operate machinery. Prasugrel is expected to have no negligible or significant impact on driving and operating machinery.

Drug interaction

drug interactions can affect the activity of the drug or cause side effects.

Patients should notify the doctor or pharmacist a list of the drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

Please see more information about drugs in the instructions for the use of drugs attached.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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